International regulatory bodies are collaborating to enhance the accessibility of vaccines and treatments for mpox, a viral illness declared a public health emergency of international concern by the World Health Organization (WHO) in August 2024. The effort is particularly focused on addressing the challenges in African countries where the disease is endemic.
The initiative follows a workshop organized by the European Medicines Agency (EMA) under the International Coalition of Medicines Regulatory Authorities (ICMRA). Participants, including representatives from international medicines regulatory authorities and WHO experts, convened virtually on October 2, 2024, to discuss strategies for supporting access to mpox medicines in the most affected countries during the ongoing outbreak.
The mpox virus, endemic in parts of Central and West Africa, has seen a surge in cases, particularly in the Democratic Republic of Congo and neighboring countries. This surge is driven by the mpox clade I strain, which is evolving into a new sub-clade Ib, similar to the clade II strain that circulated during the 2022/2023 public health emergency. A major challenge during these outbreaks has been the limited availability of medicines.
Addressing Evidence Gaps and Regulatory Pathways
The workshop addressed several critical issues, including the current epidemiological status, the availability of mpox vaccines in African countries, and efforts to fill evidence gaps regarding vaccine use in children and pregnant women. Participants also discussed the establishment of effective surveillance systems and the optimal regulatory pathways for approving new vaccines and treatments.
International regulators emphasized the necessity of conducting large clinical trials to generate the evidence required for faster development and rapid approval of mpox medicines. They also agreed that a more coordinated approach would be the most effective strategy for managing current and future public health emergencies.
Building on Past Collaborations
The meeting built upon the experience and knowledge gained from previous regulatory workshops held by ICMRA, which encouraged international collaboration, alignment, and information sharing among regulators worldwide. The discussion was moderated by Moji Adeyeye, Director General of the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC), and Marco Cavaleri, Head of Public Health Threats at EMA.
